He Purongo Mo Nga Kai Hei Arai i Te Matehuka - Dietary Diabetes Prevention Study for Maori
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
moderate carbohydrate, high protein diet (MCHP)
high carbohydrate-high fibre (HCHF) diet
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring Maori, insulin sensitivity, cardiovascular risk, diabetes prevention, diet modification
Eligibility Criteria
Inclusion Criteria: Self identify as Maori aged between 17-75 years Male and female Non-diabetic Resident of Dunedin and Invercargill BMI >27 Family history of T2D Exclusion Criteria: The presence of diabetes, renal or liver failure, or any other medical condition which is unstable and for which potential partcipants are currently having active treatment.
Sites / Locations
- Edgar National Centre for Diabetes Research
Outcomes
Primary Outcome Measures
Dietary intake as measured by 3-day weight diet records
Secondary Outcome Measures
Blood pressure
Bioelectric Impedence
Weight
Waist circumference
Total cholesterol and lipid subfractions (LDL, HDL)
Fasting insulin
Lipoprotein A + B
Inflammatory markers
Urinary albumin:creatinine ratio
Quality of life
All measures to be compared at end of study (6 months)
Full Information
NCT ID
NCT00208637
First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Edgar National Centre for Diabetes Research
1. Study Identification
Unique Protocol Identification Number
NCT00208637
Brief Title
He Purongo Mo Nga Kai Hei Arai i Te Matehuka - Dietary Diabetes Prevention Study for Maori
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Edgar National Centre for Diabetes Research
4. Oversight
5. Study Description
Brief Summary
High protein diets are popular among Maori, especially on the East Coast of the North Island. The purpose of this study was to compare the metabolic effects of a moderate carbohydrate, high protein diet (MCHP) with a high carbohydrate-high fibre (HCHF) diet on insulin sensitivity in Maori at increased risk of developing diabetes and cardiovascular disease.
Detailed Description
This was a 6-month pilot intervention study of self-identifying Maori participants in a randomised control trial conducted in Dunedin and Invercargill. The study consisted of three, two month phases and was conducted over a period of six months. Participants meeting all the inclusion criteria were randomised into three groups: moderate carbohydrate-high protein (MCHP), high carbohydrate-high fibre (HCHF) or a control group. Those randomised to the experimental diets were recommended an energy intake based on their current BMI levels. The aim of phase one was to achieve weight loss with weekly advice and support from the research team. The aim of phase two was for weight maintenance with continued weekly advice and support. Phase three consisted of a weight maintenance phase without support. Those in the control group were instructed to follow their own self selected diet plan.
Outcome was determined by examining surrogate clinical endpoints. The clinical endpoints included the following recorded measurements of anthropometric measurements, bioelectrical impedance measurements, profile of mood state questionnaires, activity questionnaires, and three day diet records were collected at 0, 2, 4 and 6 month periods. Biochemical measures of lipid profile, fasting insulin and glucose, liver functions and uric acid levels were also conducted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Maori, insulin sensitivity, cardiovascular risk, diabetes prevention, diet modification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
moderate carbohydrate, high protein diet (MCHP)
Intervention Type
Behavioral
Intervention Name(s)
high carbohydrate-high fibre (HCHF) diet
Primary Outcome Measure Information:
Title
Dietary intake as measured by 3-day weight diet records
Secondary Outcome Measure Information:
Title
Blood pressure
Title
Bioelectric Impedence
Title
Weight
Title
Waist circumference
Title
Total cholesterol and lipid subfractions (LDL, HDL)
Title
Fasting insulin
Title
Lipoprotein A + B
Title
Inflammatory markers
Title
Urinary albumin:creatinine ratio
Title
Quality of life
Title
All measures to be compared at end of study (6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Self identify as Maori aged between 17-75 years
Male and female
Non-diabetic
Resident of Dunedin and Invercargill
BMI >27
Family history of T2D
Exclusion Criteria:
The presence of diabetes, renal or liver failure, or any other medical condition which is unstable and for which potential partcipants are currently having active treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorraine Brooking, BSc, MA
Organizational Affiliation
Edgar National Centre for Diabetes Research, Dunedin, NZ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jim I Mann, FRACP, PhD
Organizational Affiliation
Edgar National Centre for Diabetes Research, Dunedin, NZ
Official's Role
Study Director
Facility Information:
Facility Name
Edgar National Centre for Diabetes Research
City
Dunedin
State/Province
Otago
ZIP/Postal Code
9001
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
22178004
Citation
Brooking LA, Williams SM, Mann JI. Effects of macronutrient composition of the diet on body fat in indigenous people at high risk of type 2 diabetes. Diabetes Res Clin Pract. 2012 Apr;96(1):40-6. doi: 10.1016/j.diabres.2011.11.021. Epub 2011 Dec 16.
Results Reference
derived
Links:
URL
http://www.otago.ac.nz/diabetes
Description
Edgar National Centre for Diabetes Research, NZ website
Learn more about this trial
He Purongo Mo Nga Kai Hei Arai i Te Matehuka - Dietary Diabetes Prevention Study for Maori
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